New Drug, Old Problems?

The internet is abuzz with dire predictions surrounding the release of a more potent form of hydrocodone. Two drug companies have announced their intent to release a hydrocodone pill with a higher content of hydrocodone, with no acetaminophen. Currently, hydrocodone is available in doses of 5, 10, and 7.5mg per pill, combined with 325 or 500mg of acetaminophen (generic drug name of Tylenol). Teva Pharmaceuticals, based in Israel, has announced their intention to release a newer, higher potency form of hydrocodone that contains 45mg per pill.  If it’s approved by the FDA, it will contain over four times the opioid firepower in one pill that the next highest dose now on the market. Teva pharmaceutical is predicting up to $500 million in sales.

It’s a little early to start saying we’re going to have another OxyContin on our hands. Since 2009, the FDA demands each pharmaceutical company that manufactures powerful opioids have a plan in place, prior to the release of a new medication, to reduce the risk of harm to the public. This program is called “REMS” for “risk evaluation and mitigation strategy.” Before a higher strength hydrocodone can be released, the manufacturer must assure the FDA that all proper precautions are being taken to avoid excessive misuse and addiction.

We will never reduce medication misuse to zero, but we can learn from the past, and use available technologies to reduce the potential for drug misuse, to prevent another version of the OxyContin situation. Teva calls its product “TD” because it’s tamper deterrent, but I can’t find any information on which technology they plan to use. It will be a sustained-release preparation that is taken once every 12 hours.

Another company, Zogenics, is preparing to release Zohydro, their brand of higher dose version of hydrocodone. They say their version contains no tamper-resistant technologies.

Do we need another high potency, long-acting opioid for pain? And do we need it at a time in history when we’re on the crest of an opioid addiction epidemic? Some experts say yes, for a startling reason: We are seeing liver failure from acetaminophen overdoses.

According to one article, the most common cause of acute liver failure is acetaminophen, the generic name of the brand Tylenol. In 1998, liver failure from acetaminophen made up only 23% of the total number of liver failure cases, while in 2003, it rose to 51% of all acute liver failure cases. Of the people with unintentional acetaminophen overdoses, 63% were taking opioids containing acetaminophen, sometimes in combination with other medication that also contained acetaminophen. (1)

There’s not a wide margin of safety with acetaminophen.  The upper limit of what’s considered to be safe is about 3 grams per day of acetaminophen, but if the person has underlying hepatitis B or C, or damage from alcohol ingestion, not even 3grams is a “safe” dose. Some hydrocodone preparations now contain 500mg per tablet, so even at therapeutic doses that’s coming close to a toxic level of acetaminophen.

Opioid addicts often take much more hydrocodone than prescribed, regardless of the amount of acetaminophen. Addicts often take 15 or 20 pills of hydrocodone per day, which could be as much as 10grms of acetaminophen per day. And they take this day after day. An ordinary person might ask, “Why would anyone take the risk of damaging their liver like that?” But that’s addiction. Addiction is about loss of control. I’ve heard dozens of addicts entering treatment voice concerns they’ve damaged their livers because of pain pill use. They describe the curious predicament of taking pills because the addiction compels them to do so, all the while hoping they won’t die from liver failure. It’s a strong statement about the strength of addiction.

While acetaminophen-free hydrocodone may not trash your liver, it can still trash your life, if you become addicted.

  1. Larson AM et al, “Acetaminophen-induced Acute Liver Failure: Results of a U.S. Multicenter, Prospective Study,”  Hepatology, 2005;42:1364-1372.

6 responses to this post.

  1. Just reading the article made me nervous for myself and others who abuse/abused hydrocodone. Although I am on Methadone and safe at the moment I cannot help but think that it’s just another drug that will victimize society. What I do not understand is in a time like now that opiate abuse is epidemic I would think they might slow the manufacturers down a bit. This Zohydro sounds like a hydrocodone form of roxicets. Which every opiate addict loves. I mean who is this going to benefit or protect? By removing the acetaminophen to protect the liver of the abusers? There already is/exist medication on the market minus the acetaminophen to help the pain relief of Cancer or Hep C or HIV related cases aren’t there? Well you can bank on the results of many deaths related to this Zohydro when this first hits the market. Just like the oxycontin. I feel so fortunate to have gotten out of this train ride to hell. I have only been on methadone for two years but where pills used to cost about 50 cents a milligram (no matter what kind) pretty much it is a dollar now. So that pill will cost on the streets at least 15 dollars apiece. Not sure how much it will cost pharmaceutically but eventually a generic and there will be a big margin of profit for the dealers. So they people/addicts that don’t die from abusing them, they will be in financial ruin etc….

    FROM THIS PARAGRAPH BELOW, FROM YOUR ARTICLE I WAS A BIT CONFUSED. Were you saying they will be making this new pill TD too?

    “We will never reduce medication misuse to zero, but we can learn from the past, and use available technologies to reduce the potential for drug misuse, to prevent another version of the OxyContin situation. Teva calls its product “TD” because its tamper deterrent, but I can’t find any information on which technology they plan to use. It will be a sustained-release preparation that is taken once every 12 hours.”

    Did you mean Teva says oxycontin is “tamper deterrent”? I wonder what is so tamper resistant about it. Addicts abuse it in every route of administration. My drug of choice in the end was Opanas and well although the pink ones were easily broken down to snort the green ones were very tricky much harder. So I did see where they made some difference there. But in the end an addict is going to find a way. I actually heard about this Zohydro a month or two ago and so the addict population finds out and sits and waits. Everybody already has the information to begin glorifying and pre-setting the market and there is already a RAVE begun. I am just so thankful I am on methadone and happy.


    • No, I meant Teva says their new product, the higher dose hydrocodone, will be “tamper deterrent.” I would like to know what this means, too, but find no solid information about the particulars as yet.


      • Oh Thank You I am sorry I misunderstood. Yeah I would be interested in what Tamper Deterrent is also…Is there anyway to find out. I mean I am sure the avenues you as a doctor has “the know how” or “the know who” to ask has come up empty then, what about the company can we ask the company? When you find out please blog it.

      • I’ll post if I’m able to learn anything. It appears the drug companies are being vague. Much also depends on the FDA, which has made noises in the past about re-scheduling hydrocodone (5, 7.5 and 10mg) to Schedule II rather than III, due to all of the abuse. It’s the most frequently prescribed opioid in the U.S., with about 139 million prescriptions dispensed in the U.S. in 2010.

  2. Posted by Ron Wilson on August 14, 2014 at 3:34 pm

    Hi, I was in the Teva study and just ended a 3 month on label treatment. I was titrated to two 45 mg tablets a day, twelve hours apart. The drug works, it is much better then taking regular Vicodin. For two reasons the first is the ability to only have to take two pills a day to get relief and the second is no Acetometophin. The TD component of the drug relates to the way the table resists crushing. It does not just turn to a powder, when you attempt to crush it the tablet sort of smashes together like a potato would so you can never really get to a powder. Not that I was trying to abuse the drug I just tested the TD portion to see what the result was. I can say that the relief that I obtained from the drug was life changing for the 8 months that I was in the trial. On Monday I took my last dose and have been prescribed 10/325 Vicodin for transition to available treatments for my crushed disk in my lower back and degenerative hip disease. Due to the inability to obtain the drug I am currently detoxing to a much lower dose of Vicodin, currently 20mg per day is what I attempting to taper to.

    I can say that the drug does exactly as it designed to do, but I regret having to detox and most likely would not allow myself to be prescribed the drug after this detox experience.

    Living in pain is the worst life possible, not being able to sleep for more than 3 hours at a time eventually takes a toll on a person. Hopefully those that need pain relief can get some help from this drug and they are able to manage the long term effects of Opiate pain management. The after party is no fun for sure. I am now on day 3 of my detox and it sucks.

    Prior to the study I was taking the maxim dose of Ibuprofen and Naproxine a day. I am currently pushing for a surgery solution to my back problems and hopefully I can find relief.

    To those who live in pain, a drug like this can provide some relief but just know that you are in for some rough times when you stop or taper.


  3. there is always talks on so many drugs. but i tell you that hydrocodone has been seen as one of the most effective drugs for easing moderate and sever pains. its restrictions come due to the fact that it’s been abused.


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